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DECREE

Detailing the implementation of a number of articles of the Pharmacy Law

THE GOVERNMENT

Pursuant to the December 25, 2001 Law on Organization of the Government;

Pursuant to the June 14, 2005 Pharmacy Law;

At the proposal of the Health Minister,

DECREES:

Chapter I

GENERAL PROVISIONS

Article 1.- Scope of regulation and subjects of application

1. This Decree details the implementation of a number of articles of the Pharmacy Law regarding:

a/ State policies on pharmacy;

b/ State management of drug prices;

c/ Conditions for trade in drugs;

d/ Management of drugs on the lists of those subject to special control;

e/ Drug quality standards, state-run drug-testing establishments and settlement of complaints about conclusions on drug quality;

f/ Competence and responsibility for state management of pharmacy.

2. This Decree shall apply to domestic and foreign agencies, organizations and individuals operating in the field of pharmacy in Vietnam.

Article 2.- Interpretation of terms

In this Decree, the terms below shall be construed as follows:

1. Lawful pharmaceutical establishments are those operating in the field of pharmacy and established under the provisions of law, including:

a/ Drug dealing establishments;

b/ Pharmaceutical sections of medical examination and treatment establishments;

c/ Pharmaceutical workers' schools;

d/ Pharmaceutical research institutes, drug-testing institutes or centers;

e/ Pharmacy state management agencies;

f/ Representative offices of foreign traders operating in the field of pharmacy in Vietnam;

g/ Other pharmaceutical establishments defined by law.

2. Posting of drug prices means the publicization of drug sale prices by way of printing, sticking, showing sale prices on drug packages or outer drug packages or displaying them on boards, papers or other means placed, hung or stuck at places where drugs are sold or supplied as provided for in Article 11 of this Decree.

Article 3.- Types of drug-dealing organizations

1. Drug-producing establishments shall cover the following types of business organizations:

a/ Drug-producing enterprises;

b/ Cooperatives, individual households producing materia medica, eastern medicines and/or drugs from materia medica.

2. Drug-wholesaling establishments shall cover the following types of business organizations:

a/ Drug-wholesaling enterprises;

b/ Cooperatives, individual households wholesaling materia medica, eastern medicines and/or drugs from materia medica;

c/ Vaccine and biologicals-wholesaling agents.

3. Drug-retailing establishments shall cover the business organization types specified in Clause 1, Article 24 of the Pharmacy Law.

4. Drug-exporting, -importing enterprises.

5. Enterprises providing drug preservation services.

6. Enterprises providing drug test services.

Chapter II

STATE POLICIES ON PHARMACY

Article 4.- Pharmaceutical projects entitled to investment preferences

Pharmaceutical projects shall enjoy investment preferences in capital, land, tax and other preferences under the provisions of law, including:

1. Projects aiming to develop the pharmaceutical industry into a spearhead econo-technical branch:

a/ Projects specified in Clause 1, Article 3 of the Pharmacy Law;

b/ Investment projects on construction of establishments for bio-equivalence experiment, drug utility assessment; pharmaceutical establishments satisfying good practice standards on production, preservation, test, distribution of drugs, clinical test of drug, cultivation, gathering and processing of materia medica.

2. Projects aiming to develop sources of materia medica and production of drugs therefrom:

a/ Projects on cultivation of materia medica, exploitation of meteria medica from nature, conservation and development of pharmaceutical gens sources;

b/ Projects on research into, proving scientific grounds and compiling standards for testing eastern drug prescriptions; survey and statistics on kinds of materia medica for drug production; collection, inheritance, popularization and rational application of eastern drug prescriptions; search for, and exploitation of the use of, new materia medica, export of materia medica.

Article 5.- Forms of support in drugs

1. Policy beneficiaries, ethnic minority areas, regions meeting with exceptional socio-economic difficulties, regions meeting with socio-economic difficulties shall enjoy drug prices not higher than the prices of drugs sold in mountainous communes, enjoy drug money exemption, reduction or supports as well as other regimes and policies on drug supports under the provisions of law.

2. The Health Ministry shall assume the prime responsibility for, and coordinate with the Ministry of Labor, War Invalids and Social Affairs, the Nationality Committee and the Finance Ministry, based on the requirements and policies on drug supports in each period, in studying the amendment and supplementation of drug support forms, regimes and policies provided for in Clause 1 of this Article, and submitting them to the Prime Minister for decision.

Article 6.- Planning on drug circulation, distribution and supply networks

Based on the tasks of socio-economic development of the country in each period, the Health Ministry shall formulate plannings and plans on development of drug circulation, distribution and supply nationwide, attaching special importance to deep-lying and remote regions, in order to ensure adequate drugs of good quality at reasonable prices, meeting people's drug demands and submit them to the Prime Minister for decision; organize the implementation of such plannings and plans after they are approved by the Prime Minister.

Article 7.- Safe, rational and efficient use of drugs, prevention and control of side effects of drugs

1. The Health Ministry shall have to stipulate the prescription, guide the safe, rational and efficient use of drugs; apply measures to prevent and control harmful effects of drugs.

2. The Health Ministry shall coordinate with the Ministry of Culture and Information in providing information on, propagating and guiding the safe, rational and efficient use of drugs within the community.

3. People's Committees at all levels shall have to direct, organize and monitor the implementation of provisions on drug information and advertisement; intensify the supply of information on, propagate and guide the safe, rational and efficient use of drugs; inspect and control drug trading in their respective geographical areas.

Chapter III

STATE MANAGEMENT OF DRUG PRICES

Article 8.- Principles on the state management of drug prices

1. The State shall manage drug prices on the principles that drug-producing, -exporting, -importing or -dealing establishments themselves shall set prices, compete on prices and submit to the inspection and control by state bodies competent to manage drug prices under the provisions of law on pharmacy and other relevant legal documents; apply measures to stabilize drug prices on the market in order to meet the requirements of servicing the people's healthcare work.

2. Drugs subject to price management under the provisions of this Decree are drugs being finished products permitted by the Health Ministry for circulation and use in Vietnam.

3. Drug-dealing establishments shall fully comply with the provisions on declaration and posting of drug prices and take responsibility before law for the declared and posted drug sale prices as provided for by the Pharmacy Law, this Decree and other relevant legal documents.

Article 9.- Types of drug prices which must be declared and posted

1. Types of drug prices include:

a/ Import prices, which are the prices inclusive of drug value calculated at prices set by exporting countries, insurance cost, freight from exporting countries to Vietnamese ports (called CIF prices for short) and exclusive of import tax (if any);

b/ Wholesale prices, which are drug sale prices among drug dealing establishments; or between drug-dealing establishments and medical examination and treatment establishments;

c/ Drug retail prices, which are the prices of drugs sold directly to users at retail establishments;

d/ Projected retail prices, which are the prices of drugs projected to be sold directly to users by drug-producing or -importing establishments.

2. Drug prices shall be declared or posted up in Vietnamese currency and calculated for the smallest packing unit.

Article 10.- Drug price declaration

1. When submitting drug registration dossiers, depending on the business form of wholesale or retail applicable to each goods item, drug-producing establishments shall declare the projected wholesale and retail prices in Vietnam, and the import prices (in case of imported drugs). Where drug-producing establishments do not have their names for drug registration, the drug-registering establishments shall declare the drug prices strictly according to regulations.

2. When submitting drug import dossiers which have not been given registration numbers, depending on the business form of wholesale or retail applicable to each goods item, drug-importing establishments shall declare the drug import prices, the projected wholesale and retail prices in Vietnam.

3. In the course of trading in drugs, drug-producing establishments and drug-importing establishments must not sell drugs at prices higher than the declared prices. In case of selling their drugs at prices higher than the declared prices, they must make re-declaration and explain the reasons therefor to drug price state management bodies before applying the new prices. In cases of selling their drugs at prices lower than the declared prices, they must observe the legal provisions against dumping.

4. The drug prices at the time of declaration and re-declaration must not be higher than the corresponding prices of drugs of the same types in regional countries with medical and commercial conditions similar to those in Vietnam at the same time. The regional countries having medical and commercial conditions similar to those in Vietnam are countries which have the following statistical indices similar to those of Vietnam:

a/ Per-capita average national income/year;

b/ Per-capita average purchasing power/year;

c/ Networks of providing services on preventive medicine, medical examination and treatment, functional rehabilitation and health improvement and drug supply to people.

The Health Ministry shall assume the prime responsibility for, and coordinate with the Trade Ministry and relevant ministries and branches in, specifically announcing the list of regional countries having medical and commercial conditions similar to those in Vietnam.

5. The drug price state management body shall have to update and publicly announce the drug prices declared by drug-dealing establishments on their websites, specialized magazines and other mass media for use as bases for patients and medical examination and treatment establishment to refer to when buying drugs; competent state agencies shall organize inspection and examination of the observance of provisions on drug price declaration by drug-producing, - registering or ' importing establishments under the provisions of this Article.

Article 11.- Posting of drug prices

1. Drug-producing, -importing, -wholesaling establishments shall post the wholesale prices of drug of every kind by way of displaying them on boards, papers or other objects placed, hung or stuck at drug sale places convenient for easily noticeable by customers and competent state bodies and shall not sell them at prices higher than the posted prices.

2. Drug-retailing establishments shall post the retail prices of drug of every kind by way of printing, writing or sticking them on drug packages or outer packages and shall not sell drugs at prices higher than the posted prices.

3. Medical examination and treatment establishments which supply assorted drugs on the lists of those largely used by medical examination and treatment establishments in service of emergency, medical examination and treatment demands of patients at the establishments where these kinds of drugs are purchased not under the provisions of Clause 2, Article 12 of this Decree, shall post the supply prices of drugs of every kind. Drug supply prices at medical examination and treatment establishments shall not be higher than the common retail prices of the same kinds of drugs in the same geographical areas and at the same time.

Article 12.- Management of drug prices paid by state budget and health insurance

1. The drug price state management body shall have to announce the maximum prices of drugs paid by state budget and health insurance once every 6 months or in case of price fluctuation.

The Health Ministry shall base on the socio-economic development situation in each period to ensure adequate quality drugs at reasonable prices, meeting the people's demands, and coordinate with the Finance Ministry, the Trade Ministry and other relevant agencies in guiding in detail the determination and announcement of maximum prices of drugs provided for in this Clause.

2. The purchase of drugs on the lists of drugs largely used in public medical examination and treatment establishments and drugs to be paid by state budget shall be effected through bidding under the provisions of law on bidding, ensuring the following principles:

a/ Prioritizing the purchase of home-made drugs of the same types, equivalent quality and with prices not higher than import drug prices at the time of bidding;

b/ The bid-wining prices must not be higher than the current maximum prices announced at the latest time provided for in Clause 1 of this Article.

3. The Health Minister shall assume the prime responsibility for, and coordinate with the Minister of Planning and Investment and the Finance Minister in, guiding in detail the bidding for drugs as provided for in Clause 2 of this Article.

Article 13.- Drug price state management body

Vietnam Pharmacy Management Department of the Health Ministry shall act as the body assisting the Health Minister in performing the function of state management of drug prices.

The Heath Minister shall define the drug price-managing functions and tasks of the Vietnam Pharmacy Management Department.

Chapter IV

DRUG DEALING CONDITIONS

Section 1. CONDITIONS AND PROCEDURES FOR GRANT OF PHARMACEUTICAL PRACTICE CERTIFICATES

Article 14.- Pharmaceutical practice certificates

1. Pharmaceutical practice certificates shall be granted to pharmaceutically professional managers of drug-dealing establishments, suitable to each type of business organization. Pharmaceutical practice certificate grantees must satisfy the conditions specified in Clause 1, Article 13 of the Pharmacy Law and the provisions of this Decree.

2 Each individual shall be granted only one pharmaceutical practice certificate and perform the professional management of only one type of drug-dealing organization.

3. The competence to grant pharmaceutical practice certificates shall comply with the provisions of Clause 3, Article 13 of the Pharmacy Law.

Article 15.- Professional diplomas, certificates, practicing duration for being granted pharmaceutical practice certificates

1. Pharmaceutical practice certificate grantees must each possess one of the following diplomas, depending on the requirements on each type of drug-dealing organization:

a/ The pharmaceutical university diploma;

b/ The intermediate pharmaceutical school diploma;

c/ The druggist diploma;

d/ The intermediate medical school diploma;

e/ The medical university diploma or the university diploma in biology;

f/ The traditional medicine university or intermediate school diploma;

g/ The galelic physician or herbalist diploma, the certificate of traditional prescriptions and traditional medicine or pharmacy qualification.

The diplomas and certificates specified at Point g, Clause 1 of this Article shall be stipulated by the Health Minister in accordance with the socio-economic conditions and medical examination and treatment demands of people in each locality in each period.

2. Conditions on diplomas and practicing duration for pharmaceutically professional managers of drug-producing establishments:

a/ Pharmaceutically professional managers of drug-producing establishments must each possess the diploma defined at Point a, Clause 1 of this Article and have a practicing duration of at least 5 years at a lawful pharmaceutical establishment;

b/ Pharmaceutically professional managers of vaccine and biologicals-producing establishments must each possess one of the diplomas defined at Points a, e of Clause 1 of this Article and have a practicing duration of at least 5 years at a lawful pharmaceutical establishment.

c/ Pharmaceutically professional managers of cooperatives or individual business households producing materia medica, eastern medicines, drugs from materia medica must each possess one of the diplomas defined at Points a, b, f and g, Clause 1 of this Article and a practicing duration of at least 2 years at a lawful pharmaceutical establishment.

3. Conditions on diploma and practicing duration for pharmaceutically professional managers of drug-wholesaling establishments:

a/ Pharmaceutically professional managers of drug- wholesaling enterprises must each possess the diploma defined at Point a, Clause 1 of this Article and have a practicing duration of at least 5 years at a lawful pharmaceutical establishment;

b/ Pharmaceutically professional managers of vaccine and/or biologicals-producing establishments must each possess one of the diplomas defined at Points a and e, Clause 1 of this Article and have a practicing duration of at least 5 years at a lawful pharmaceutical establishment;

c/ Pharmaceutically professional managers of cooperatives, individual business households producing materia medica, eastern medicines, drugs from materia medica must each possess one of the diplomas defined at Points a, b, f and g, Clause 1 of this Article and a practicing duration of at least 2 years at a lawful pharmaceutical establishment;

d/ Pharmaceutically professional managers of vaccine, biologicals sale agents must each possess one of the diplomas specified at Points a, b, d and e, Clause 1 of this Article and have a practicing duration of at least 2 years at a lawful pharmaceutical establishment.

4. Conditions on diploma and practicing duration for drug- retailing establishment owners:

a/ Owners of drugstores in centrally-run cities, provincial cities or towns must possess the diploma defined at Point a, Clause 1 of this Article and have a practicing duration of at least 5 years at a lawful pharmaceutical establishment; for other geographical areas, they must possess the diploma defined at Point a, Clause 1 of this Article and have a practicing duration of at least 2 years at a lawful pharmaceutical establishment. University pharmacists shall be proposed for the grant of practicing certificates immediately after their graduation;

b/ Owners of drug counters must possess the diploma of intermediate vocational school or higher and have a practicing duration of at least 2 years at a lawful pharmaceutical establishment;

c/ Owners of drug sale agents of enterprises must possess the druggist diploma or higher and have a practicing duration of at least 2 years at a lawful pharmaceutical establishment;

d/ Managers of drug chests of health stations must possess the professional qualification of druggist or higher and have a practicing duration of at least 2 years at a lawful pharmaceutical establishment; in cases where such persons are not available, they must be managed by persons possessing the professional qualifications of assistant doctor or higher.

5. Conditions on diploma and practicing duration for pharmaceutically professional managers of drug-exporting and/or -importing enterprises:

a/ The enterprises' pharmaceutical practice certificate grantees meeting the conditions prescribed in Clause 1, Article 24 of this Decree shall be regarded as professionally pharmaceutical managers of drug-importing enterprises;

b/ Pharmaceutical practice certificate grantees of drug dealing enterprises shall be regarded as professionally pharmaceutical managers of drug-exporting enterprises.

6. Conditions on diploma and practicing duration for pharmaceutically professional managers of drug preservation service-providing enterprises:

a/ Pharmaceutically professional managers of drug preservation service-providing enterprises must possess the diploma defined at Point a, Clause 1 of this Article and have a practicing duration of at least 3 years at a lawful pharmaceutical establishment;

b/ Pharmaceutically professional managers of vaccine and/or biologicals preservation service- providing enterprises must possess one of the diplomas defined at Points a and e, Clause 1 of this Article and have a practicing duration of at least 3 years at a lawful pharmaceutical establishment.

7. Conditions on diploma and practicing duration for pharmaceutically professional managers of drug testing service-providing enterprises:

a/ Pharmaceutically professional managers of drug testing service-providing enterprises must possess the diploma defined at Point a, Clause 1 of this Article and a practicing duration of at least 5 years at a lawful pharmaceutical establishment;

b/ Pharmaceutically professional managers of vaccine and/or biological testing service-providing enterprises must possess one of the diplomas prescribed at Points a and e, Clause 1 of this Article and have a practicing duration of at least 5 years at a lawful pharmaceutical establishment.

Article 16.- Dossiers of application for grant, renewal, extension, re-grant of pharmaceutical practice certificates

1. Dossiers of application for pharmaceutical practice certificates of Vietnamese citizens shall each comprise:

a/ An application for pharmaceutical practice certificate;

b/ Valid copies of professional diplomas;

c/ The curriculum vitae certified by the president of the commune/ward/township People's Committee of the locality where the applicant resides or by the head of the agency where such person is working, if he/she is an official or public servant;

d/ A certificate of good health for professional practice, issued by a medical examination and treatment establishment prescribed by the Health Ministry, which is still valid within the 6 month- time limit as from the date of issuance;

e/ A written certification of the practicing duration at a lawful pharmaceutical establishment by the head of such establishment;

f/ Written commitment to observe the provisions of relevant legal documents on pharmacy;

g/ A notarized or authenticated copy of the applicant's identity card;

h/ Two portrait photos of 4 cm x 6 cm size.

2. Dossiers of application for pharmaceutical practice certificates for foreigners on overseas Vietnamese shall each comprise:

a/ Papers prescribed at Points a, b, d, e, f and h, Clause 1 of this Article;

b/ The judicial record certified by a competent agency of the concerned foreign country;

c/ The work permit or written certification of being a member of the Management Board or the Directorate of the drug-dealing establishment;

d/ The passport copy notarized or certified by a diplomatic mission of the country of which he/she is a citizen.

Pharmaceutical diplomas and other papers defined at Points b and e, Clause 1 and Point b of Clause 2 of this Article, which are issued by foreign agencies or organizations or notarized, certified, must be consularly legalized and translated into Vietnamese; the translation must be notarized according to the provisions of Vietnamese law.

3. Dossiers of application for renewal of pharmaceutical practice certificates due to damage, tear and wear, change of residence of individual registrant for pharmaceutical practice shall each comprise:

a/ An application for renewal of the pharmaceutical practice certificate;

b/ A valid copy of the approval of residence change by a competent body, for case of change of residence of the individual having registered for pharmaceutical practice;

c/ The original pharmaceutical practice certificate;

d/ Two portrait photos of 4 cm x 6 cm size.

4. Dossiers of application for extension of pharmaceutical practice certificates:

a/ An application for extension of the pharmaceutical practice certificate;

b/ A certificate of good health for professional practice, issued by a medical examination and treatment establishment prescribed by the Health Ministry, which is still valid within the 6 month- time limit counting from the date of issuance;

c/ A copy of the issued pharmaceutical practice certificate;

d/ Two portrait photos of 4 cm x 6 cm size.

5. Dossiers of application for re-grant of pharmaceutical practice certificates which are lost shall each comprise:

a/ An application for regrant of pharmaceutical practice certificate;

b/ The declaration on the loss of pharmaceutical practice certificate, with certification of the ward/commune police office of the locality where the applicant lost his/her pharmaceutical practice certificate;

c/ Two portrait photos of 4 cm x 6 cm size.

Article 17.- Validity and term of pharmaceutical practice certificates

1. A pharmaceutical practice certificate shall has a term of 5 years as from the date of issuance. Three months before its expiry, if wishing to continue his/her professional practice, the concerned individual must compile a dossier of application for extension according to the provisions of Clause 4, Article 16 of this Decree. The maximum extension duration shall be 5 years and the number of extensions shall not be limited.

2. Validity of pharmaceutical practice certificates:

a/ Pharmaceutical practice certificates issued or extended by the Health Minister shall be valid for professional practice registration throughout the country.

b/ Pharmaceutical practice certificates issued or extended by directors of provincial/municipal Health Services shall be valid within the provinces or centrally-run cities where they are issued.

In case of relocation of professional practice offices to other provinces or cities, pharmaceutical practice registrants must compile their application for a new pharmaceutical practice certificate. The dossiers of application for pharmaceutical practice certificates at new locations shall comply with the provisions of Clause 1, Article 16 of this Decree, enclosed with the original certification of termination of professional practice in the capacity as pharmaceutically professional managers of drug-dealing establishments or owners of drug-retailing establishments and the pharmaceutical practice certificates must be returned to the provincial/municipal Health Services which have issued or extended such certificates. Within 5 days after receipt of an application for certification of termination of professional practice for carrying out procedures for relocation of professional practice office, the local Health Services which have issued the pharmaceutical practice certificates must reply in writing.

3. The term of validity of a regranted or renewed certificate shall correspond to the remaining duration of the lost pharmaceutical practice certificate.

Article 18.- Order and competence for grant, re-grant, renewal, extension of pharmaceutical practice certificates

1. Within 30 days after receipt of a valid dossier of application for grant, regrant, renewal or extension of a pharmaceutical practice certificate, the dossier-receiving agency shall have to organize appraisal for grant, regrant, renewal or extension of pharmaceutical practice certificate; if refusing to grant, re-grant, renew or extend, the dossier-receiving agency shall have to reply in writing and clearly state the reasons therefor.

2. The competence for grant, re-grant, renewal or extension of pharmaceutical practice certificates shall comply with the provisions of Clause 3, Article 13 of the Pharmacy Law. A pharmaceutical practice certificate shall be made in two copies: one copy shall be kept at the issuing agency and one shall be handed to the applicant.

3. The Health Ministry shall set the form of pharmaceutical practice certificate.

Article 19.- Withdraw of pharmaceutical practice certificates

1. Pharmaceutical practice certificates shall be withdrawn in the following cases:

a/ They are granted ultra vires;

b/ The pharmaceutical practice certificate grantees later fall into one of the cases provided for in Clause 2, Article 13 of the Pharmacy Law;

c/ The pharmaceutical practice certificate grantees die or are declared dead by the court.

2. Upon detecting cases of violation which are subject to withdrawal of pharmaceutical practice certificates under the provisions of Clause 1 of this Article, the pharmaceutical practice certificate-granting agencies shall decide on the withdrawal thereof.

3. For pharmaceutical practice certificates previously issued by the Health Ministry, which, under the provisions of this Decree, fall under the granting competence of provincial/municipal Health Services, when being withdrawn under the provisions of Clause 1 of this Article, the provincial/municipal Health Services shall have to withdraw and keep them and report thereon to the Health Ministry.

Section 2. CONDITIONS AND PROCEDURES FOR GRANT OF CERTIFICATES OF FULL SATISFACTION OF DRUG BUSINESS CONDITIONS

Article 20.- Grantees of certificates of full satisfaction of drug business conditions

1. Certificates of full satisfaction of drug business conditions shall be granted to drug-dealing establishments which satisfy the conditions prescribed for each type of drug dealing under the provisions of this Chapter.

2. Drug-dealing establishments can only operate at the business locations and within the business scope stated in the certificates of full satisfaction of drug business conditions.

Article 21.- Conditions for grant of certificates of full satisfaction of drug business conditions

1. Pharmaceutically professional managers must possess pharmaceutical practice certificates suitable to each form of business organization of production establishments.

2. Material and technical foundations as well as personnel of drug-producing establishments must satisfy good practice standards on drug production according to the schedule on application of good practice standards mentioned in Article 27 of this Decree.

Article 22.- Conditions for grant of certificates of full satisfaction of drug business conditions for drug-wholesaling establishments

1. Pharmaceutically professional managers must possess pharmaceutical practice certificates suitable to each form of organization of business of wholesale establishments.

2. Material and technical foundations and personnel of drug-wholesaling establishments must satisfy good practice standards on drug distribution according to the schedule on application of good practice standards mentioned in Article 27 of this Decree.

Article 23.- Conditions for grant of certificates of full satisfaction of drug business conditions, for drug retailing establishments

1. Drug-retailing establishment owners must possess pharmaceutical practice certificates suitable to each form of organization of business of retail establishments.

2. Material and technical foundations and personnel must satisfy good practice standards on drugstores according to the schedule on application of good practice standards mentioned in Article 27 of this Decree.

Article 24.- Conditions for grant of certificates of full satisfaction of drug business conditions, for drug-exporting or -importing enterprises

1. Drug-producing or -wholesaling enterprises which have certificates of full satisfaction of drug business conditions and have drug warehouses up to good practice standards on drug preservation shall be permitted to import drugs according to the provisions of law on pharmacy, regulations of the Health Ministry, and relevant legal provisions.

2. Enterprises which have certificates of full satisfaction of drug business conditions shall be permitted to export drugs.

Article 25.- Conditions for grant of certificates of full satisfaction of drug business conditions, for drug preservation service-providing enterprises

1. Pharmaceutically professional managers must possess pharmaceutical practice certificates suitable to types of drug preservation service-providing enterprises.

2. Material and technical foundations and personnel of drug preservation service-providing enterprises must satisfy good practice standards on drug preservation according to the schedule on application of good practice standards mentioned in Article 27 of this Decree.

Article 26.- Conditions for grant of certificates of full satisfaction of drug business conditions, for drug testing service-providing enterprises

1. Pharmaceutically professional managers must possess pharmaceutical practice certificates suitable to types of drug testing service-providing enterprises.

2. The material and technical foundations and personnel of drug testing service-providing enterprises must satisfy good practice standards on drug testing according to the schedule on application of good practice standards mentioned in Article 27 of this Decree.

Article 27.- Schedule on application of good practice standards

The Health Minister shall prescribe the schedule on application of good practice standards on drug production, distribution, preservation and test, drugstores and on material medica culture, gathering and processing.

Article 28.- Dossiers of application for grant, supplementation, extension, re-grant, renewal of certificates of full satisfaction of drug business conditions

1. A dossier of application for a certificate of full satisfaction of drug business conditions shall comprise:

a/ An application for a certificate of full satisfaction of drug business conditions;

b/ A valid copy of the pharmaceutical practice certificate of the pharmaceutically professional manager suitable to the form of business organization; a valid copy of the business registration certificate;

c/ The lists of staff members, professional equipment, material and technical foundations;

d/ For drug sale agents of drug-dealing enterprises, vaccine and/or biologicals wholesale agents of vaccine and/or biologicals-producing enterprises, in addition to the papers defined at Points a, b and c, they must also produce the valid copies of agency contracts between the principals and the agent heads.

2. Dossiers of application for supplementation of the business scope in the certificate of full satisfaction of drug business conditions shall each comprise:

a/ An application for supplementation of the drug business scope;

b/ A valid copy of the issued certificate of full satisfaction of drug business conditions;

c/ The lists of staff members, professional equipment, material and technical foundations for the business scope proposed to be supplemented.

3. Dossiers of application for extension of the certificate of full satisfaction of drug business conditions shall each comprise:

a/ An application for extension of the certificate of full satisfaction of drug business conditions;

b/ A valid copy of the pharmaceutical practice certificate of the pharmaceutically professional manager, suitable to the form of business organization; a valid copy of the business registration certificate; a copy of the issued certificate of full satisfaction of drug business conditions;

c/ The lists of staff members, professional equipment, material and technical foundations;

d/ A report on business results in the last 5 years according to the regulations of the Health Ministry.

4. Dossiers of application for re-grant of lost certificate of full satisfaction of drug business conditions shall each comprise:

a/ An application for regrant of the certificate of full satisfaction of drug business conditions;

b/ The declaration on the loss of the certificate of full satisfaction of drug business conditions, certified by the commune/ward-level police office of the locality where the certificate of full satisfaction of drug business conditions was lost.

5. Dossiers of application for renewal of the certificate of full satisfaction of drug business conditions due to damage, wear and tear, change of the pharmaceutically professional manager; change of the name of the drug-dealing establishment but without change of the business location; change of the business registration office in cases where the business registration office is other than the business operation location, which were granted the certificate of full satisfaction of drug business conditions shall each comprise:

a/ An application for renewal of the certificate of full satisfaction of drug business conditions;

b/ A valid copy of the pharmaceutical practice certificate of the pharmaceutically professional manager, in case of change of pharmaceutically professional manager;

c/ A valid copy of the written approval of the renaming of the drug-dealing establishment by the business registrar, in case of renaming the drug-dealing establishment;

d/ A valid copy of the written approval of the relocation of the drug business registration office by the business registrar, in case of relocation of drug business registration office;

e/ The original certificate of full satisfaction of drug business conditions.

Article 29.- Validity and term of certificates of full satisfaction of drug business conditions

1. A certificate of full satisfaction of drug business conditions shall have a term of 5 years after it is issued. Three months before its expiry, if wishing to continue with their business, individuals and organizations shall compile a dossier of application for extension of the certificate of full satisfaction of drug business conditions as provided for at Clause 3, Article 28 of this Decree. The extension duration shall be 5 years.

2. The use duration of regranted certificates of full satisfaction of drug business conditions shall be equivalent to the remaining duration of the lost certificates.

Article 30.- Order and competence for grant, re-grant, supplementation, renewal, extension of certificates of full satisfaction of drug business conditions

1. The order for grant, regrant, supplementation, renewal, extension of certificates of full satisfaction of drug business conditions is provided for as follows:

a/ Within 30 days after receiving a valid dossier of application for grant, regrant, supplementation, renewal or extension of a certificate of full satisfaction of drug business conditions, the dossier-receiving agency must organize appraisal for grant, regrant, supplementation, renewal or extension of the certificate of full satisfaction of drug business conditions; if refusing to grant, regrant, supplement, renew or extend the certificate, it shall reply in writing and clearly state the reasons therefor;

b/ Where a dossier of application for grant, regrant, supplementation, renewal or extension of the certificate of full satisfaction of drug business conditions is invalid, within 10 working days after the receipt thereof, the dossier-receiving agency shall notify such in writing to the applicant for supplementation and finalization of the dossier.

2. The competence for grant, regrant, supplementation, renewal or extension of certificates of full satisfaction of drug business conditions shall comply with the provisions of Clause 3, Article 11 of the Pharmacy Law. A certificate of full satisfaction of drug business conditions shall be issued in two copies: one copy shall be kept at the issuing agency and one shall be handed to the applicant.

3. The Health Ministry shall prescribe the form of certificates of full satisfaction of drug business conditions.

Article 31.- Withdrawal of certificates of full satisfaction of drug business conditions

1. Certificates of full satisfaction of drug business conditions shall be withdrawn in the following cases:

a/ They are issued ultra vires;

b/ The pharmaceutically professional managers of drug-dealing establishments do not possess pharmaceutical practice certificates;

c/ The drug-dealing establishments fail to satisfy the business conditions for each type of business organization defined in Articles 21, 22, 23, 24, 25 and 26 of this Decree;

d/ Twelve months after being granted the certificates of full satisfaction of drug business conditions, the drug-dealing establishments do not operate;

e/ The drug-dealing establishments terminate their operation.

2. Upon detection of violation cases subject to withdraw of certificates of full satisfaction of drug business conditions under the provisions of Clause 1 of this Article, the agencies competent to issue certificates of full satisfaction of drug business conditions, defined in Clause 3, Article 11 of the Pharmacy Law, shall decide to withdraw such certificates.

3. The certificates of full satisfaction of drug business conditions, which were previously issued by the Health Ministry but, under the provisions of this Decree, fall under the issuing competence of provincial/municipal Health Services, when being withdrawn, shall be withdrawn and kept by provincial/municipal Health Services which shall report thereon to the Health Ministry.

Chapter V

MANAGEMENT OF DRUGS ON THE LIST OF THOSE SUBJECT TO SPECIAL CONTROL

Section 1. MANAGEMENT OF ADDICTIVES, PSYCHOTROPICS, PRE-SUBSTANCES

USED AS DRUGS

Article 32.- Business conditions

Establishments dealing in addictives, psychotropics and pre-substances used as drugs must satisfy the following conditions:

a/ The drug business conditions defined in Chapter II of the Pharmacy Law and Chapter IV of this Decree;

b/ The conditions defined in the Government's Decree No. 80/2001/ND-CP of November 5, 2001, guiding the control of lawful activities related

to narcotics in the country and Decree No. 58/2003/ND-CP of May 29, 2003, defining the control of import, export and transit through Vietnamese territory of narcotics, pre-substances, addictives

and psychotropics, and other relevant provisions of law.

Section 2. MANAGEMENT OF RADIOACTIVE DRUGS

Article 33.- Business conditions

Establishments dealing in radioactive drugs, in addition to the drug business conditions prescribed in Chapter II of the Pharmacy Law and Chapter IV of this Decree, must also satisfy the following conditions:

1. Having a permit for radiation safety, issued by the Ministry of Science and Technology.

2. Radiation safety officials must be trained in radiation safety under programs prescribed jointly by the Ministry of Science and Technology and the Health Ministry and must possess certificates of training in radiation safety, issued by training establishments permitted by the Ministry of Science and Technology.

Article 34.- Preparation and use of radioactive drugs

1. The preparation and use of radioactive drugs shall be permitted to be carried out in nuclear medical establishments which are granted radiation safety permits by the Ministry of Science and Technology.

2. The licensed nuclear medical establishments which wish to use radioactive drugs must make the estimates according to a form set by the Health Ministry for consideration and concurrently report thereon to the Ministry of Science and Technology (The Nuclear Radiation Safety Control Department) for monitoring.

Chapter VI

DRUG QUALITY STANDARDS, STATE-RUN DRUG TESTING ESTABLISHMENTS AND SETTLEMENT OF COMPLAINTS ABOUT CONCLUSIONS ON DRUG QUALITY

Article 35.- Promulgation of Vietnam Pharmacopoeia

1. Vietnam Pharmacopoeia is a book of national standards on medicines, which is compiled by Vietnam Pharmacopoedia Council and submitted to the Health Minister for promulgation. The Vietnam Pharmacopoedia Council shall be set up by the Health Minister.

2. The order and procedures for formulation and promulgation of national standards on medicines shall comply with the provisions of law on standards and technical regulations.

Article 36.- Application of foreign pharmacopoeia and international pharmacopoeia

Drug-dealing establishments in Vietnam may apply standards inscribed in foreign pharmacopoeia or international pharmacopoeia already registered by the establishments and approved by the Health Ministry.

Article 37.- Organizational system of state-run drug- testing establishments

1. Central state-run drug-testing establishments include the Central Drug Testing Institute, Ho Chi Minh City Drug Testing Institute, the regional drug-testing centers, the National Institute for Vaccines and Biologicals Testing.

2. Local state-run drug-testing establishments include provincial/municipal drug-testing centers.

3. The organization and operation of state-run drug-testing establishments shall comply with current provisions of law.

Article 38.- Operation of state-run drug-testing establishments

1. Central state-run drug-testing establishments shall:

a/ Check and assess the quality, appraise the quality standards of drugs and other products at the Health Ministry's requests;

b/ Conduct scientific research; provide technically professional direction for local state-run drug-testing establishments;

c/ Conduct training and re-training of testers in professional testing techniques;

d/ Provide testing services;

e/ Propose to the Health Minister technical measures to control drug quality suitable to the socio-economic development conditions of the country;

f/ Conduct other activities under the provisions of relevant law.

3. Local state-run drug-testing establishments shall examine the quality of drugs circulated in their respective provinces or centrally- run cities and conduct other activities under provisions of relevant law.

3. The Health Minister shall specify the functions and tasks of state-run drug-testing establishments after reaching agreement with the Ministry of Home Affairs.

Article 39.- Competence to determine drug quality-testing results

1. Central state-run drug-testing establishments are competent to determine drug quality-testing results strictly according to the registered quality standards of drug-producing or -importing establishments which have asked permission for the circulation thereof, and assist the Health Minister in determining drug quality nationwide under the assignment by the Health Minister, comply with the provisions of this Decree and other relevant provisions of law.

The Vietnam Pharmacy Management Department shall assist the Health Minister in making conclusions on drug quality nationwide, based on the drug quality-testing results of central state-run drug-testing establishments.

2. Local state-run drug-testing establishments are competent to determine the drug quality-testing results strictly according to the registered quality standards of drug-producing or -importing establishments, which have asked for permission for circulation thereof and assist directors of provincial/municipal Health Services in determing the drug quality in areas under their management according to the provisions of this Decree and relevant provisions of law.

Provincial/municipal Health Services shall assist the presidents of provincial/municipal People's Committees in making conclusions on drug quality within the areas of their respective management, based on drug quality-testing results of local state-run drug-testing organizations.

3. In case of complaints about conclusions on drug quality, the Health Ministry shall designate drug-testing establishments to determine the drug quality-testing results on the principle that such testing establishments shall not be the disputing parties and have facilities up to the minimum standards equivalent to those of the testing establishments with testing results in dispute.

4. The order, procedures and competence for settlement of complaints about drug quality conclusions shall comply with the provisions of the law on complaints and denunciations.

Chapter VII

DIVISION OF RESPONSIBILITIES FOR STATE MANAGEMENT OF PHARMACY

Article 40.- Responsibilities of the Health Ministry

The Health Ministry shall be answerable to the Government for performing the tasks of state management of pharmacy throughout the country, including:

1. To assume the prime responsibility for elaborating and submitting to competent authorities for promulgation or promulgate according to its competence normative documents on pharmacy; policies, strategies, planning and plans on pharmaceutical development and implementation guidance after they are promulgated;

2. To formulate and submit to the Government, the Prime Minister specific projects on pharmaceutical development for annual consideration of investment priority and preferences; to direct the execution of projects after they are approved;

3. To assume the prime responsibility for, and coordinate with relevant ministries and branches in, promulgating according to its competence and organizing the implementation of normative documents on pharmacy; drug business conditions, drug price management, the schedule on application of good practice standards;

4. To assume the prime responsibility for, and coordinate with the Ministry of Planning and Investment and the Finance Ministry in, guiding in detail the bidding for different kinds of drugs provided for in Article 49 of the Pharmacy Law;

5. To assume the prime responsibility for, and coordinate with relevant ministries and branches in, performing the state management of drug prices;

6. To assume the prime responsibility for, and coordinate with the Ministry of Education and Training in, formulating plans on training and re-training of pharmaceutical human resources and submit them to the Prime Minister for decision.

7. To assume the prime responsibility for, and coordinate with the Ministry of Home Affairs, the Ministry of Labor, War Invalids and Social Affairs in, guiding the implementation of regimes and policies on pharmaceutical human resources at grassroots medical establishments, with priority given to regions meeting with exceptional socio-economic difficulties and areas hit by socio-economic difficulties;

8. To conduct activities of international cooperation and integration on pharmacy according to provisions of law;

9. To inspect and examine the observance of law on pharmacy; to settle pharmacy-related complaints and denunciations and handle violations of law on pharmacy according to provisions of law.

Article 41.- Responsibilities of other ministries

1. The Finance Ministry, the Trade Ministry and the Industry Ministry shall coordinate with the Health Ministry in formulating and announcing maximum prices of drugs of various kinds, specified in Article 49 of the Pharmacy Law.

2. The Finance Ministry shall coordinate with the Health Ministry in formulating and submitting to competent bodies for promulgation or promulgating according to its competence the policies, measures and normative documents guiding the management of drug prices, drug tax rates, statistics on drugs actually exported or imported via border- gates and solutions to drug price stabilization, drug reserves for circulation according to provisions of law.

3. The Ministry of Planning and Investment:

a/ To coordinate with the Health Ministry in formulating and submitting to the Prime Minister for promulgation the planning on development of pharmaceutical industry; distribute investment projects for the pharmaceutical sector, approve plans on national drug reserve fund;

b/ To coordinate with the Finance Ministry and the Health Ministry in formulating and submitting to competent authorities for promulgation or promulgate according to its competence the policies, measures and normative documents guiding the management of drug prices, solutions to drug price stabilization, drug reserve for circulation according to provisions of law.

4. The Trade Ministry:

a/ To assume the prime responsibility for, and coordinate with the Health Ministry in, monitoring the development of domestic and world pharmaceutical markets in service of the formulation and proposition of policies on drug price management for submission to competent bodies for promulgation or promulgate according to its competence.

b/ To coordinate with the Health Ministry in formulating and submitting to competent bodies for promulgation or promulgate according to its competence the planning on drug distribution and circulation networks throughout the country; to promote drug export and import; to prevent and combat counterfeit drugs, smuggled drugs, drugs of unidentified origin from their circulation on market;

c/ To coordinate with the Health Ministry in formulating and submitting to competent bodies for promulgation or promulgate according to its competence and organize the implementation of legal provisions on ecommerce in drug business according to provisions of law.

5. The Industry Ministry shall coordinate with the Health Ministry in formulating and submitting to competent bodies for promulgation or promulgate according to its competence, and organize the implementation of, the planning on development of Vietnam's pharmaceutical industry, and production of pharmaco-chemical raw materials.

6. The Ministry of Science and Technology shall coordinate with the Health Ministry in formulating and promulgating the lists of radioactive medicines and guiding in detail the business conditions and use thereof.

7. The Ministry of Home Affairs shall coordinate with the Health Ministry in defining the specific functions, tasks and operations of state-run drug-testing establishments.

8. The Ministry of Culture and Information shall coordinate with the Health Ministry in promulgating legal documents guiding the activities of drug information and advertisement on the mass media and Internet.

9. The Ministry of Agriculture and Rural Development shall coordinate with the Health Ministry in formulating and organizing the implementation of plans on culture and development of materia medica sources.

10. The Ministry of Public Security shall coordinate with the Health Ministry in preventing and fighting crimes in the production and circulation of counterfeit drugs, low-quality drugs, smuggled drugs, drugs of unidentified origin on the market.

Article 42.- Responsibilities of provincial/municipal People's Committees

1. To promulgate according to their competence guiding documents on pharmacy in their respective geographical areas.

2. To direct the implementation of policies and measures on drug price management in their respective geographical areas according to provisions of law.

3. To examine and inspect the observance of legal provisions on pharmacy by organizations and individuals operating in their respective localities; to handle violations of law on pharmacy according to competence.

4. To direct local professional agencies to coordinate with provincial/municipal Health Services in implementing national policies on drug prices and supporting local pharmaceutical enterprises in developing the production of drugs.

Chapter VIII

IMPLEMENTATION PROVISIONS

Article 43.- Implementation effect

1. This Decree shall take effect 15 days after its publication in "CONG BAO" and replace the Regulation on Preventive and Curative Medicines, promulgated together with Decree No. 23-HDBT of January 24, 1991, of the Council of Ministers. The provisions on private practice of traditional pharmacy, private practice of pharmacy, private practice of vaccines, biologicals in the Government's Decree No. 103/2003/ND-CP of September 12, 2003, detailing the implementation of a number of articles of the Ordinance on Private Medical and Pharmaceutical Practice; the provisions of the Government's Decree No. 120/2004/ND-CP of May 12, 2004, on management of prices of preventive and curative medicines for human use and the previous regulations contrary to this Decree shall all be annulled.

2. Organizations and individuals that are granted pharmaceutical practice certificates or certificates of full satisfaction of conditions for pharmaceutical practice prior to October 1, 2005, shall be entitled to continue their professional practice until the end of the term defined in their pharmaceutical practice certificates or certificates of full satisfaction of conditions for pharmaceutical practice. Three months before the expiry thereof, if wishing to continue with their professional practice, such organizations and individuals shall have to carry out procedures for grant of pharmaceutical practice certificates or certificates of full satisfaction of drug business conditions according to the provisions of the Pharmacy Law and this Decree.

3. For state-run pharmaceutical enterprises, including equitized ones, where their pharmaceutically professional managers have not yet been granted a pharmaceutical practice certificate, or for enterprises which have not been granted a certificate of full satisfaction of drug business conditions, the professional managers of the enterprises shall compile dossiers of application for grant of a pharmaceutical practice certificate suitable to their type of business organization; enterprises shall have to compile dossiers of application for a certificate of full satisfaction of drug business conditions immediately after meeting the requirements on material and technical foundations and personnel conditions according to the schedule on application of good practice standards mentioned at Article 27 of this Decree.

Article 44.- Implementation responsibility

1. The Health Minister shall have the responsibility to guide and organize the implementation of this Decree.

2. Other ministers, heads of ministerial-level agencies, heads of government-attached agencies, and presidents of provincial/municipal People's Committees shall have to implement this Decree.